The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in charge of biological and chemical substances, as well as electronic products. The agency was established under the Council of Ministers resolution no (1) dated 07/01/1424 H and functions under the Council of Ministers as an independent body that reports to the President of Council of Ministers.
SFDA is in charge of overseeing the safety, security and effectiveness of medical devices, ensuring their accuracy, and controlling and supervising manufacturing facilities, as well as overseeing the importation and registration of these products.
A list of SFDA regulations can be found here on our website.
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自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
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